Tenapanor Hydrochloride

WALTHAM, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the company will present data supporting the company’s first-in-class retainagogue, IBSRELA® (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the upcoming Digestive Disease Week Conference (DDW), to be held May 3-6, 2025, in San Diego. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults. Title: Safety and Tolerability of Tenapanor in Pediatric Patients With Irritable Bowel Syndrome With Constipation: An Analysis of Blinded Safety Data from a Phase 3 Study and its Open-Label ExtensionAuthors: Thomas Wallach, Mihaela Ringheanu, Ana Roig Cantisano, Yang Yang, Karishma Raju, Jocelyn Tabora, Susan EdelsteinPoster Number: Sa1643Date/Time: May 3, 2025, from 12:30 PM to 1:30 PM PDT Title: Neither Tenapanor nor its Major Metabolite Were Detected in the Breast Milk of Healthy Lactating Females After 4 Days of Dosing: A Phase 1, Open-Label, Pharmacokinetic StudyAuthors: Darren Brenner, Karishma Raju, Kenji Kozuka,Yang Yang, Suling Zhao, Susan EdelsteinPoster Number: Sa1673Date/Time: May 3, 2025, from 12:30 PM to 1:30 PM PDT Title: Patient-Reported IBS-C Symptom Severity Correlates Positively With Financial Burden: Results From the IBS in America 2024 Real-World SurveyAuthors: Eric Shah, Luisa Scott, Johannah Ruddy, Elizabeth Stremke, Laura Williams, Baharak MoshireePoster Number: Mo1257Date/Time: May 5, 2025, from 12:30 PM to 1:30 PM PDT In addition to the poster presentations during DDW, Ardelyx is sponsoring a Product Theater titled: “Integrating a Different Mechanism of Action, a different Class of Therapy, Into the Treatment of Adults with IBS-C,” on May 4, 2025, from 12:50-1:35 PM PDT, where Satish Rao, MD, and Christina Hanson, NP, will share important clinical considerations in managing adult patients with IBS-C. The presentation will include interactive patient case studies, along with efficacy and safety data from two Phase 3 clinical trials. About IBSRELA® (tenapanor)IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, thus retaining luminal water content, which accelerates intestinal transit time and results in a softer stool consistency. IBSRELA has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In a rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability. About Irritable Bowel Syndrome with Constipation (IBS-C)Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by both abdominal pain and altered bowel movements, estimated to affect 12 million people in the U.S. IBS-C is associated with significantly impaired quality of life, reduced productivity, and substantial economic burden. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTSIBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. CONTRAINDICATIONSIBSRELA is contraindicated in: patients less than 6 years of age due to the risk of serious dehydrationpatients with known or suspected mechanical gastrointestinal obstruction WARNINGS AND PRECAUTIONSRisk of Serious Dehydration in Pediatric Patients IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Diarrhea Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient. MOST COMMON ADVERSE REACTIONS The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%). INDICATION IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults. Please see full Prescribing Information, including Boxed Warning, for additional risk information. About ArdelyxArdelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook. Investor and Media Contacts: Lindsey Manuellmanuel@ardelyx.com

Accelerates Globalization of Innovative Products with Operating Cash Flow Surging 31.13% YoY SHANGHAI, March 25, 2025 /PRNewswire/ -- On March 25, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"or "the Group"; Stock Code: 600196.SH, 02196.HK), a leading global pharmaceutical and healthcare company driven by innovation, announced its annual results for the year ended 31 December 2024 ("the Reporting Period"). In 2024, Fosun Pharma further focused on the business development of innovative drugs and high-value devices, achieving operating revenue of RMB41.07 billion and net profit attributable to shareholders of RMB2.77 billion, representing an increase of 16.08% YoY. Fosun Pharma continuously optimize supply chain management to enhance operational efficiency, recording an operating cash flow of RMB4.48 billion with an increase of 31.13% YoY, surpassing the growth rate of operating profit. In addition, Fosun Pharma continues to advance lean management across quality enhancement, cost control, efficiency improvement, cycle management, and innovation R&D, driving operational efficiency and expanding profitability. During the Reporting Period, the gross margin minus the selling and distribution expense ratio improved by 2.45 percentage points YoY; and, excluding the impact of newly acquired enterprises during the Reporting Period and the same period last year, administrative expenses declined by RMB355 million. Fosun Pharma always takes innovation as a core driving force in its development. Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. During the Reporting Period, Fosun Pharma continuously optimized its innovative R&D system while maintaining stable R&D investment, focusing on key pipeline strengths and enhancing efficiency through system integration. In 2024, Fosun Pharma's total R&D expenditure amounted to RMB5.55 billion, with R&D expenses totaling RMB3.64 billion. The R&D expenditure in the pharmaceutical manufacturing segment amounted to RMB4.91 billion, accounting for 16.98% of pharmaceutical business revenue. There are over 80 major pipeline projects on innovative drugs and biosimilars (calculated by indications). In addition, during the Reporting Period, the pharmaceutical manufacturing segment of Fosun Pharma submitted 220 patent applications, including 3 American patent applications, 18 PCT applications, and Fosun Pharma has obtained 66 licensed invention patents authorization. Accelerating Innovation Transformation and the Internationalization of Innovative Products Focusing on unmet clinical needs, Fosun Pharma continuous to push forward its innovation transformation and the development and commercialization of innovative products, expanding into regulatory markets such as the U.S. and the EU. During the Reporting Period, 7 innovative products/biosimilars with a total of 16 indications independently developed and licensed-in by Fosun Pharma were approved for launch, and 8 innovative products/biosimilars had entered the pre-launch approval/critical clinical stage. Fosun Pharma also had 18 innovative products/biosimilar projects (calculated by indications) initiated clinical trials. In the field of lung cancer, Fosun Pharma has developed a comprehensive layout in innovative drugs and precision diagnostics and treatment to benefit patients globally. Fosun Pharma's self-developed innovative anti-PD-1 monoclonal antibody, Han Si Zhuang (Serplulimab Injection), is the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), and it remains the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC. During the Reporting Period, Han Si Zhuang also received approval in Chinese mainland for the treatment of non-squamous non-small cell lung cancer (nsNSCLC), and this also marked its third indication in the field of lung cancer, further expanding its reach. To date, Han Si Zhuang has been approved for marketing in over 30 countries and regions, including China, the European Union, and several Southeast Asian nations, benefiting more than 100,000 patients. In addition, to help more lung cancer patients obtain early diagnosis and treatment in a more minimally invasive way, the Ion Bronchial Navigation Operation Control System (Ion System) of Intuitive Fosun, Fosun Pharma's associated company, received NMPA approval in March 2024 and has been commercially deployed. In high-incidence cancers such as breast and gastric cancers, Fosun Pharma's self-developed monoclonal antibody(mAb) biosimilar Han Qu You (Trastuzumab Injection) has been approved for launch in over 50 countries and regions, including China, the European Union, the U.S., Canada and Australia, and has been included in the health insurance directories in countries such as China, UK, France, and Germany. To date, Han Qu You has benefited over 240,000 patients. The HER2-targeted innovative monoclonal antibody HLX22 for gastric cancer treatment and the novel endocrine therapy HLX78 (lasofoxifene) for breast cancer are currently under international multi-center Phase III clinical trials. Additionally, the biosimilar candidate HLX11 (pertuzumab) has had its new drug applications submitted and accepted in both China and the U.S., injecting new momentum into global expansion. In addition, Fosun Pharma is also advancing the development of rare disease drugs. Its self-developed MEK1/2 selective inhibitor Luvometinib tablets, (Project Code: FCN-159), has had its new drug applications for two indications—treatment of adult dendritic cell and histiocytic tumors, and treatment of plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1) in children aged 2 years and older—accepted by the NMPA and placed in the priority review process . In the non-oncology field, during the Reporting Period, Fosun Pharma's self-developed and licensed-in rabies vaccine (Vero cell) for human use (freeze dried), Pu Rui Ni (Pretomanid Tablets), Han Da Yuan (Adalimumab Injection) received approval for four new indications, and Su ke Xin (Avatrombopag Malate Tablets) was approved for its second indication in China; meanwhile, the new drug applications for a biosimilar of denosumab HLX14 under development were accepted by the European Medicines Agency (EMA), Health Canada and the FDA, respectively. Continuously Enhancing Global Operations and Bilateral Licensing Cooperation Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, licensing, manufacturing and operations as well as commercialization. In 2024, overseas revenue reached RMB11.30 billion, accounting for 27.51% of total revenue. During the reporting period, Fosun Pharma continues to promote the building of production system with international quality standard, laying a solid foundation for the overseas distribution of preparations. As of the end of 2024, all production lines of the domestic subsidiaries under the pharmaceutical manufacturing segment of Fosun Pharma obtained domestic GMP certifications and 10 production lines had passed GMP certification in major regulatory markets such as the U.S. and the EU. Fosun Pharma's pharmaceuticals and medical devices businesses now primarily cover major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia, with an overseas commercialization team of over 1,000 employees. In the U.S., Fosun Pharma's in-house generic drug team has continued to grow, establishing partnerships with major distributors and group purchasing organizations (GPOs) to drive the sales of formulation products. Meanwhile, Fosun Pharma has established its innovative drug team in the U.S. and is preparing for the commercialization of its anti-PD-1 monoclonal antibody (mAb), serplulimab injection. In Europe, Gland Pharma has built localized manufacturing capabilities through its subsidiary, Cenexi. Sisram Medical has expanded its global direct sales offices to 12, with its marketing network now covering over 110 countries and regions. The share of direct sales revenue has further increased to 87%. Meanwhile, Breas Medical's marketing network has expanded across key mature markets, including Europe, the United States, Japan, and Australia. In emerging markets, Fosun Pharma's sales network in Africa now covers over 40 countries and regions. The company continues to advance the Côte d'Ivoire park project to establish localized pharmaceutical manufacturing and supply in Africa. In February 2025, Fosun Pharma launched a new pharmaceutical and medical device sales platform in Nanning, gradually enhancing its registration and commercialization capabilities in Southeast Asia to expand its presence in the region. Fosun Pharma is also actively expanding into the Middle East market. During the reporting period, Henlius, a subsidiary of Fosun Pharma, entered into a strategic partnership with SVAX to establish a joint venture in Saudi Arabia. This collaboration aims to enhance the accessibility of innovative and high-value products in the MENAT region (Middle East, North Africa, and Turkey). Fosun Pharma continues to strengthen its global licensing collaboration, further enhancing its international influence and competitiveness. On the out-licensing front, Henlius, a subsidiary of Fosun Pharma has forged deep partnerships with over 20 leading global biopharmaceutical companies, including Accord, Abbott, Eurofarma, KGbio, Organon, and Dr. Reddy's, to jointly expand global markets. These collaborations comprehensively cover major biologics markets in Europe and the U.S., as well as numerous emerging markets. To date, its approved biologics have benefited more than 750,000 patients worldwide. Fosun Pharma continues to expand its product pipeline in core therapeutic areas through strategic global collaborations. Licensed-in products such as the antiemetic Akynzeo® (netupitant/palonosetron capsules), long-lasting recombinant human granulocyte colony-stimulating factor product (Pei Jin) and the drug for heart failure and hypertension treatment (Yi Xin Tan) have been included in the National Medical Insurance Drugs Catalogue, benefiting a wide range of patients. Fosun Pharma has obtained exclusive development and commercialization rights for Tenapanor Hydrochloride Tablets (Wan Ti Le), a first-in-class phosphate-lowering drug with a novel mechanism. In February 2025, the drug received approval from the National Medical Products Administration (NMPA) in China for the treatment of hyperphosphatemia in adult dialysis patients with chronic kidney disease (CKD). This approval marks a new era of multi-mechanism phosphate control, bringing new hope to dialysis patients with hyperphosphatemia. During the reporting period, Fosun Pharma's licensed product Daxxify® (DaxibotulinumtoxinA-lanm) became the first of its kind approved in China. The product received NMPA approval for the improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Accelerating Localization of Innovative Products in China to Achieve High-quality Development As a global innovation-driven pharmaceutical and healthcare company, Fosun Pharma actively introduces internationally advanced technologies and products to the Chinese market, benefiting patients and customers. During the reporting period, Fosun-Insightec, a joint venture established with Insightec in China, successfully achieved sales of magneticresonance image guided focused ultrasound brain therapy system ("MRgFUS brain therapy system") for brain treatment. Additionally, the headquarters and industrial base of Intuitive Fosun, an associated company, was officially inaugurated in the Zhangjiang International Medical Park in Shanghai. This facility integrates R&D, manufacturing, and training, further accelerating the localization of the da Vinci Robotic surgical systems in China. To further enhance its leading position in tumor immunotherapy, Fosun Pharma increased its stake in its cell therapy platform, Fosun Kairos, to 100% during the reporting period. The company will continue to collaborate with Kite Pharma to advance the development and commercialization of its licensed products, Axi-Cel (marketed as Yi Kai Da ) and Brexu-Cel (investigational project FKC889), in Chinese mainland, Hong Kong S.A.R and Macao S.A.R. Yi Kai Da became the first in China to introduce an innovative outcome-based payment model. As of the end of 2024, Yi Kai Da has benefited over 800 lymphoma patients, been included in more than 110 provincial and municipal government-backed insurance programs and over 80 commercial insurance plans, and has been registered in more than 180 treatment centers across 28 provinces and municipalities nationwide. While maintaining steady operations, Fosun Pharma remains committed to its corporate social responsibilities. In 2024, the company received multiple domestic and international accolades for its significant progress in ESG, including recognition as one of China's ESG Listed Company Pioneer 100, Deloitte's China Best Managed Companies, Charity Star, and Forbes 2024 China ESG 50 list. Additionally, Fosun Pharma's MSCI ESG rating remained at A. "Fosun Pharma will continue to adhere to innovation-driven and global development strategies, actively embrace AI, concentrate resources on core businesses, and persistently advance lean management and enhance operational efficiency." Wu Yifang, Chairman of Fosun Pharma said, "We aim to grow in tandem with China's biopharmaceutical industry and stride into a new phase of high-quality development. Upholding our mission to 'create better health for families worldwide', we will maintain a patient-centric approach, address unmet clinical needs, deepen innovation transformation and global expansion, and strive to become a global leader in healthcare innovation and integration." About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; SSE: 600196, HKEX: 02196) is a leading innovation-driven global healthcare company operating in the fields of pharmaceuticals, medical devices & diagnostics, and healthcare services. Through its strategic alliance with Sinopharm Group Co., Ltd., Fosun Pharma further extends its capabilities in pharmaceutical commerce. Over the past 30 years since its establishment, Fosun Pharma has maintained deep roots in China while strategically expanding its global presence. The company has been actively implementing its "4IN" strategy -Innovation, Internationalization, Intelligentization, and Integration, with core business operations now spanning major overseas markets including the United States, Europe, Africa, India, and Southeast Asia. At present, Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. This multidimensional approach accelerates the translation of innovative therapies into clinical practice, systematically addressing critical unmet medical needs worldwide. Looking ahead, Fosun Pharma remains anchored in its core values of "Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership". By advancing its global innovation engine and operational excellence, the company strives to be a global leader to integrate pharmaceutical and healthcare innovations, creating better health for families worldwide. SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED